Early Assessment of AKI After TAAA RepairNCT04087161
Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
An observational study of Early Assessment of AKI After TAAA Repair, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system. Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Assessment of AKI After TAAA Repair
- What is being tested?
- Nephrocheck bed side testing of AKI
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective, open TAAA repair
Who may be able to join
- elective open TAAA repai
- 18-80 years
- no pregnancy
Who cannot join
- emergency treatment participation in another Trial renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.
Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe
- Being tested
- Nephrocheck bed side testing of AKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephrocheck bed side testing of AKIOther
Usage of Nephrocheck system to assess AKI after open TAAA repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury after open TAAA repair
Acute kidney injury defined according to the KDIGO classification and its association with the Nephrocheck assessment results
Measured: 90 days after surgery
Secondary outcomes (1)
Mortality, major adverse events such as any complication
Any severe adverse Outcome after open TAAA repair and its association with the Nephrocheck assessment results
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Dec 2019
- Primary completion25 Apr 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Assessment of AKI After TAAA RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Münster, University Hospital, Department of Vascular Surgery, Berlin, University medicine Charité, Department of Vascular Surgery
- Responsible party
- Principal investigator, Alexander Gombert, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087161
- Sponsor's protocol ID
- 29012015
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Doukas P, Frese JP, Eierhoff T, Hellfritsch G, Raude B, Jacobs MJ, Greiner A, Oberhuber A, Gombert A. The NephroCheck bedside system for detecting stage 3 acute kidney injury after open thoracoabdominal aortic repair. Sci Rep. 2023 Jul 9;13(1):11096. doi: 10.1038/s41598-023-38242-2.
PubMed 37423933
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
- ClinicalTrials.gov ID
- NCT04087161
- Acronym / sponsor ID
- 29012015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Münster, University Hospital, Department of Vascular Surgery, Berlin, University medicine Charité, Department of Vascular Surgery
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.
Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective, open TAAA repair
Key inclusion criteria (3 listed)
- elective open TAAA repai
- 18-80 years
- no pregnancy
Key exclusion criteria (1 listed)
- emergency treatment participation in another Trial renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nephrocheck bed side testing of AKIUsage of Nephrocheck system to assess AKI after open TAAA repair | Other | – |
Primary outcome
Acute kidney injury after open TAAA repair
Time frame: 90 days after surgery
Acute kidney injury defined according to the KDIGO classification and its association with the Nephrocheck assessment results
1 secondary outcome
Mortality, major adverse events such as any complication
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 37423933Doukas P, Frese JP, Eierhoff T, Hellfritsch G, Raude B, Jacobs MJ, Greiner A, Oberhuber A, Gombert A. The NephroCheck bedside system for detecting stage 3 acute kidney injury after open thoracoabdominal aortic repair. Sci Rep. 2023 Jul 9;13(1):11096. doi: 10.1038/s41598-023-38242-2.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Assessment of AKI After TAAA Repair, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury after open TAAA repair (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.